Glassia
Generic name: alpha1-proteinase inhibitor (human)
Treatment for: Alpha-1 Proteinase Inhibitor Deficiency
IV-AAT BLA Accepted for Review
Kamada's Biologics License Application for IV-AAT to Treat Alpha-1 Antitrypsin Deficiency is Accepted for Review by the US Food and Drug Administration
NESS ZIONA, Israel--(BUSINESS WIRE)--Aug 4, 2009 - Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that the United States Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for intravenous alpha-1 antitrypsin (IV-AAT), the Company's flagship product for the treatment of alpha-1 antitrypsin deficiency.
Acceptance of the BLA by the FDA indicates that the submission satisfies the FDA's preliminary requirements for review. The product will be evaluated within the standard Prescription Drug User Fee Act (PDUFA) timeframe, resulting in an action date in 2Q 2010. An inspection of Kamada's manufacturing facilities in Israel is expected to be performed by the FDA during the review period.
About IV-AAT
Kamada has developed a unique, high purity, liquid, ready-to-use human plasma derived AAT for the treatment of alpha-1 deficiency. The product is produced using a sophisticated, proprietary chromatographic purification method.
About Kamada
Kamada is a public biopharmaceutical company (TASE: KMDA) developing, producing and marketing a line of specialty life-saving biopharmaceuticals. Licensed and marketed worldwide, several of these specialty therapeutics are currently undergoing advanced clinical trials. Additional information is available at www.kamada.com.
Contact: Kamada
Yaron Cherny, +972 8-940 6472
Business Development manager
yaronc@kamada.com
***
Posted: August 2009
Related articles
- Kamada Wins FDA Approval for Glassia - a New Liquid, Ready-to-Use Treatment for Alpha-1 Antitrypsin Deficiency - July 6, 2010
- Kamada Submits U.S. Biologics License Application for the First Liquid, Ready to Use AAT for the Treatment of Alpha-1 Antitrypsin Deficiency - June 2, 2009
Glassia (alpha1-proteinase inhibitor (human)) FDA Approval History
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